JP2006521886A - Body fluid sampling structure and technology - Google Patents

Abstract

An apparatus operable to extract a bodily fluid sample including at least one skin penetrating member, an actuator, a controller, and a housing for mounting at least one skin penetrating member extending from the apparatus. Another device for extracting bodily fluids is an inner bore, an outer diameter, and at least one axially movable disposed within the inner bore (or alternatively disposed around the outside of the skin penetrating member). At least one skin penetrating member having a hollow tubular member. Yet another apparatus includes at least one skin penetrating member, an actuator, a controller, a housing for mounting the at least one skin penetrating member, and a sensor that measures an electrical parameter transmitted through the at least one skin penetrating member. Related methods are also disclosed.

Description

  The present invention relates to a device, structure and technique for effectively obtaining a bodily fluid sample in a reliable, minimally invasive and / or substantially painless manner.

(Background of the Invention)
Prior art studies have shown that there are a wealth of techniques and devices for obtaining bodily fluid samples.

(Summary of the Invention)
In accordance with the present invention, the state of the art has progressed through the provision of devices and techniques such as those described below for obtaining a sample of bodily fluid that is reliable, minimally invasive and / or substantially painless.

  According to one aspect, the present invention provides an apparatus that operates to extract a body fluid sample, the apparatus comprising at least one skin penetrating member and an actuator for extending and / or retracting the at least one skin penetrating member. And a controller for controlling the actuator, at least one skin penetrating member and a housing for mounting the actuator.

  According to another aspect, the present invention provides an apparatus for extracting bodily fluid, the apparatus comprising at least one needle having an inner bore and an outer diameter, and at least one shaft installed within the inner bore. A hollow tubular member movable in the direction is included. As an alternative, the present invention includes an axially movable tube arranged on the outside of the skin penetrating member.

  According to additional aspects, the present invention provides at least one skin penetrating member, an actuator for extending and / or retracting the at least one skin penetrating member, a controller for controlling the actuator, and at least one skin. A housing for installing a penetrating member and an actuator, wherein the housing allows at least one skin penetrating member to be extended from the device, and measures electrical parameters transmitted through the at least one skin penetrating member A bodily fluid sampling device including a skin sensor is provided.

  According to yet another aspect, the present invention provides a method of extracting a bodily fluid sample, the method comprising: (i) inserting at least one skin penetrating member into the skin at a sampling site at a predetermined distance. (Ii) withdrawing at least one skin penetrating member at least partially from a predetermined distance and (iii) withdrawing a bodily fluid sample from the sampling site.

(Detailed description of the invention)
Exemplary arrangements and techniques for obtaining bodily fluid samples are described below with reference to the accompanying drawings.
As used herein, the term “body fluid” is intended to encompass blood, interstitial fluid, and combinations thereof. The principle of the present invention was developed mainly for the purpose of obtaining body fluid samples from humans, but the arrangement and technique described herein can be applied to obtain body fluid samples from other animals. Imagine.

According to one aspect, the present invention provides an arrangement and technique for automating and precisely controlling a bodily fluid sampling procedure.
As used herein, the term “automatic” is intended to encompass arrangements and techniques that can obtain bodily fluid samples with little or no active intervention. However, the “automatic” and the arrangements and techniques described herein may also be initiated, manipulated and terminated by a subject whose body fluid is being sampled, or a third party such as a caregiver. Includes possible arrangements and techniques.

  The arrangement and technique according to the present invention includes the penetration depth of the skin penetrating member, the speed at which the skin penetrating member is inserted, the frequency at which the skin penetrating member is inserted, the residence time of the skin penetrating member within the subject's body, and the skin penetration Allows precise control of a number of bodily fluid sampling parameters, such as member longitudinal (ie, axial), rotational and / or angular articulation and manipulation.

  An exemplary embodiment of an arrangement constructed in accordance with the principles of the present invention is shown in FIGS. Basically, an arrangement constructed according to the principles of the present invention provides a reliable, controllable and autonomous operation of the skin penetrating member relative to the skin of the subject being tested to obtain a body fluid sample.

  Examples showing the above arrangement are shown in FIGS. In the illustrated embodiment, the arrangement 1 includes, as main components, a base member 2, a frame 3, an actuator 4, a controller 5, a skin penetrating member 6, and means for driving an actuator such as a motor M.

  A suitable arrangement constructed in accordance with the principles of the present invention may have numerous other details and features. Some of these details and features are shown in FIG. Of course, the embodiment of the arrangement 1 shown in FIG. 2 is merely illustrative. Many other arrangements are possible within the scope of the present invention. For example, arrangements including one or more features shown in FIG. 2 can be included within the scope of the present invention. On the other hand, an arrangement that includes several features in addition to the features shown in the example of FIG. 2 can also be imagined.

  As shown in FIG. 2, the arrangement 1 is configured such that the skin penetrating member can be inserted into the skin S, substantially perpendicular to the surface of the skin S (ie, at 90 °), or at a non-orthogonal angle α. Is done. For example, arrangement 1 can be configured such that skin penetrating member 6 is inserted into skin S at an angle of approximately 10-40 °. Without being limited to any particular theory or structure, insertion of a skin penetrating member at a non-orthogonal angle, such as α, is not absolutely necessary to obtain satisfactory results, but such as fracture or capillary action. It is possible to provide a benefit that increases the chance of contact with the body fluid generating element contained in the skin S.

  The skin penetrating member 6 can have any suitable structure. For example, the skin penetrating member 6 can comprise at least one of the following types of elements: one or more or a combination of needles or lancets.

  The skin penetrating member 6 can be installed in a large apparatus by any suitable technique. In the illustrated embodiment, the skin penetrating member 6 is carried by or through a guide side member 7 disposed in the base 2. The guide side material 7 precisely controls the progress of the skin penetrating member 6 through it. In another embodiment of the invention, the skin penetrating member 6 includes a very small diameter or gauge, needle or lancet. Such small diameter penetrating members create smaller flaws. This can be beneficial in terms of reducing the pain associated with penetration into the skin S. The reward involved in the use of such small diameter members is that they lack structural integrity. Thus, when a very small diameter skin penetrating member is inserted into the skin S, buckling or other distortion of the skin penetrating member is often observed. When used, the guide side member 7 acts to counteract the above tendency to buckle or otherwise deform the small diameter skin penetrating member.

According to the embodiment shown, a mounting block 8 for carrying and placing the guide side material 7 in the base 2 is also provided.
According to one aspect of the present invention, a device such as the illustrated arrangement 1 is movable or wearable by the subject whose body fluid is being sampled. The principles of the present invention appear to be potentially useful in connection with wearable devices, and particularly when incorporated into wearable glucose monitoring devices. Benefits provided to such wearable devices by the structure, arrangement and technique of the present invention are the reliable acquisition of bodily fluids, the ability to voluntarily obtain bodily fluid samples, and the minimization of pain associated with obtaining bodily fluid samples. including.

  Thus, an arrangement constructed in accordance with the principles of the present invention can include means that allow the device to be worn by a subject whose body fluid is being sampled. For example, in the exemplary embodiment, the arrangement 1 can comprise a securing strap 9, which can be mounted over the base 2 and looped around the wearer's limb, such as an arm, leg, etc. To. The fixing strap 9 can take any suitable shape, such as a Velcro strap. Further, the adhesive 10 can be used to secure the sampling device to the wearer's body. The adhesive 10 can be provided instead of or in addition to the fixing strap 9.

According to an alternative embodiment, an arrangement similar to that shown in FIGS. 1 and 2 can be configured in the form of a handheld device (not shown), which can be easily grasped by the user and applied to the skin. Can be held and acted upon.
As described above, an arrangement constructed in accordance with one embodiment of the present invention allows the insertion of a skin penetrating member with respect to the surface area of the skin S, either at a 90 ° angle or at a non-orthogonal angle α. One suitable structure that provides this function is shown in FIG. That is, the base 2 can comprise a hinge member 11 that is attached to the frame 3 by a pivot 12. The hinge member 11 can also include a suitable adjustment mechanism 13. In the illustrated embodiment, the adjustment mechanism 13 includes a plurality of holes or recesses in the hinge 11 that mesh with corresponding protrusions provided on the frame 3. Other suitable adjustment mechanisms are obviously available.

  According to one aspect of the present invention, the skin penetrating member 6 can be operated in conjunction with the actuator 4 and body fluid sample collection mechanism by any suitable arrangement. In the arrangement 1 shown in FIG. 2, such an arrangement includes a hollow tubular member 14. This member is installed at the second end of the skin penetrating member 6, and this end faces the sharp distal end of the skin penetrating member inserted into the surface of the skin S. When the skin penetrating member 6 is provided in the form of a hollow needle, the hollow tubular member 14 provides fluid communication with the inner bore of the needle. (An alternative design according to the present invention has a skin penetrating member such as a solid lancet with a hollow outer tube disposed therearound). The hub member 15 is further provided over the skin penetrating member 6 and can be coupled thereto in any suitable manner, for example, by an adhesive. The hub member 15 can include a flange 16 that defines a stop surface facing a shoulder or stop surface 17 provided on the guide side member 7. Thus, since the hub member 15 is fixedly connected to the skin penetrating member 6, the travel distance of the skin penetrating member 6 is limited when the flange 16 abuts against the shoulder or the stop surface 17, as is apparent in FIG. Or stopped. Thus, such a configuration provides a suitable technique for limiting the penetration depth of the skin penetrating member 6. This penetration depth limited configuration provides a safety benefit and should control for actuator malfunction. The travel distance of the skin penetrating member 6 and the associated penetration depth into the skin S (ie, measured perpendicularly from the surface of the skin S), for example, limits the desired distance between the flange 16 and the shoulder 17. By doing so, it is readily apparent that any desired value can be set in a relatively simple manner. According to a non-limiting example, the distance traveled by the skin penetrating member 6 of the present invention is limited to approximately 80 mm in the above-described manner, and the associated penetration depth is limited to approximately 2.5 mm.

As further shown in FIG. 2, the syringe body 1818 can be attached to the hub member 15 at one end, while an operable attachment mechanism 19 is provided at the opposite end.
According to a further aspect of the invention, a suitable arrangement may comprise the actuator 4. The specific depth of such an actuator 4 can vary greatly. For example, as shown in FIG. 2, the actuator may comprise a traveler or shaft 20. This shaft is operatively associated with the syringe body 18 via an attachment device 19 as well as a housing or casing member 21. As shown in FIG. 2, the shaft member 20 is movable in the longitudinal direction within the casing 21. Alternative embodiments of the actuator 4 included within the scope of the present invention also include a spring loaded actuator and a rotary screw actuator.

  One benefit of an arrangement provided consistent with the principles of the present invention is to control the operation of the skin penetrating member in a precise and autonomous manner as much as possible. In this regard, one or more connections 22 are provided that communicate with a suitable controller (eg 5, FIG. 1). The connecting portion may be an electrical or pneumatic one. The controller 5 can include any suitable device or mechanism including suitable electronics, such as a central processing unit (CUP). A suitable controller facilitates control over the skin penetrating member 6 when entering the skin, the residence time of the skin penetrating member within the skin, and the frequency with which the skin penetrating member is penetrated into the skin. For example, the controller 5 advances the skin penetrating member 6 into the skin at specific times during the day (eg, every few hours) to obtain a body fluid sample that can be analyzed to determine glucose content. Can be used. Furthermore, the traveling speed of the skin penetrating member 6 can be controlled to a traveling speed of approximately 1 to 4 meters / second, for example.

  The actuator 4 can also be operatively associated with a device such as a motor M to provide motive power thereto. Any suitable motor or motive power generating element can be utilized. By way of non-limiting example, motor M includes an electric stepper motor. It is within the scope of the present invention to provide not only pure longitudinal travel to the skin penetrating member, but also rotational and / or angular articulation, even if the mechanism is utilized to drive the actuator 4. Is within. Further, it is within the scope of the present invention to provide vibration and / or heat to the skin penetrating member.

The controller 5 can be operatively associated with the motor M to provide the above functionality.
According to another aspect, an arrangement constructed in accordance with the principles of the present invention can be further provided to facilitate the collection of bodily fluid samples generated within the surface of the skin S by actuation of the skin penetrating member 6. . According to the example shown in FIG. 2, the arrangement 1 comprises a structure for applying a vacuum pressure V, thereby facilitating the collection of body fluid samples. In this regard, according to an exemplary embodiment, a vacuum collar 23 is provided, which connects a vacuum line 24 to the inside of the syringe body 15 via a fitting 25. While it is within the scope of the present invention that a bodily fluid sample can be drawn from the end of the hollow member 14, it is also beneficial to draw bodily fluid from the inside of the hollow member 14. As shown in FIG. 2, the hollow member 14 can include a fluid coupling member 26 for this purpose. It is further anticipated that a separate line can connect the vacuum line 24 to the fluid connection member 26 (not shown). In this regard, a separate line can be connected to the end of the fitting 25, which is inside the syringe body 15 and the opposite line of this line is connected to the fluid connection member 26. Illustratively, a vacuum on the order of 0.18 to 0.25 psi is suitable for this purpose.

  For discussion, the following various additional structures, arrangements, and techniques are described. The following structures, arrangements and techniques can be used in connection with the arrangements described above, but it will be appreciated that the invention is not so limited. In other words, the structures, arrangements, and techniques described below can obviously be used independently of, or incorporated into, some or all of the foregoing aspects of the invention.

  Another form of the invention involves the manipulation of skin and / or wounds either before, during or after insertion of the skin penetrating member into the surface of the skin. Such manipulation can increase the reliability with respect to obtaining a bodily fluid sample and can reduce the invasiveness and pain associated with obtaining an appropriate bodily fluid sample in a reliable and repeatable manner. According to the present invention, mechanical, vacuum-assisted, thermal and / or chemical stimuli are included.

  According to one embodiment, the arrangement 30 can be utilized to provide mechanical stimulation of the skin before, during or after insertion of the skin penetrating member. The arrangement 30 can be generally described as a modified component 2 'of the base member 2 described above, as shown in FIGS. 3A and 3B. According to one form, the arrangement 30 comprises opposing translatable blocks 32, 34. These blocks 32, 34 are grasped by the user of the device and compressed along the direction indicated by arrow P, thereby allowing the skin S to be sandwiched between them, as shown in FIG. 3B. As an alternative, instead of grasping and pressurizing by hand, the blocks 32, 34 can be operated in different ways, for example by associating with a suitable motor and / or pneumatic mechanism (not shown). According to the illustrated embodiment, a spring member 36 is provided between the opposing blocks 32 and 34 to provide a return force after the applied pressure or actuation mechanism is removed.

  As described above, the arrangement 30 described above can be used to sandwich the skin S prior to insertion of the skin penetrating member. By doing so, blood and other body fluids can rush to the site corresponding to the site through which the skin penetrating member penetrates the skin S. This abundance effect increases the likelihood of obtaining an appropriate sample of body fluid.

  As an alternative, for example, once the wound is healed by insertion of the skin penetrating member, the arrangement 30 can be utilized. In this regard, the pinching action shown in FIG. 3B can be utilized to apply force to the wound to keep it open, thereby facilitating the collection of bodily fluids from the wound caused by inserting the skin penetrating member. .

  According to another aspect, the present invention utilizes devices and / or techniques that involve thermal stimulation of the skin at the site where the skin penetrating member is to be inserted, either before, during or after insertion. A number of devices and techniques that provide this thermal stimulation are clearly possible. For example, as shown in FIG. 2, one or more infrared heating elements 29 can be provided to produce the desired thermal stimulus. Other options such as direct contact, resistance, or other heating devices are envisaged.

  Applying a thermal stimulus to the skin prior to insertion of the skin penetrating member will enrich the blood going to the stimulated area, thereby increasing the likelihood of obtaining an appropriate body fluid sample upon insertion of the skin penetrating member. When applied during insertion, the same basic effect can be used to prevent clotting and can be used to enrich the body fluid going to the wound site. If a thermal stimulus is provided after withdrawal of the skin penetrating member, the same effect can be utilized to enrich the body fluid that goes to the wound site, prevent coagulation, and the like.

  According to another aspect, the present invention provides an apparatus, structure and technique for utilizing a vacuum that stimulates the skin at the area where a skin penetrating member is to be inserted and / or at the wound site itself within the skin. Including. Generally speaking, this aspect of the invention includes vacuum assisted operation. A waved vacuum can be applied to repeatedly lift and release the skin in the area around the wound site. The use of such a wave-like vacuum can be utilized to work the skin and produce a warming effect. This effect is similar to that produced by mechanical stimulation or rubbing. This stimulation results in an abundance of bodily fluid at the site where the skin penetrating member is to be inserted, thus increasing the likelihood of obtaining an appropriate sample of bodily fluid. Applying a waved vacuum over the skin around the wound after insertion of the skin penetrating member increases the ability to draw body fluid from the skin and increases the amount of body fluid useful for sampling. Thus, using the waved vacuum above, maximizing the amount of bodily fluid that can be withdrawn by insertion of the skin penetrating member, thereby allowing the use of a smaller diameter needle or lancet to produce an appropriate sample volume, Thus, it is clear that this will result in low pain levels for the user of the device. Furthermore, the use of the wave-like vacuum reduces the need for relatively bulky mechanical components and drive mechanisms, thereby facilitating a more compact design. The application of a vacuum that can be used for skin manipulation can also serve the dual purpose of drawing and transporting a bodily fluid sample from the wound site.

  An exemplary embodiment of this aspect of the invention is shown in FIGS. 4A-4D. According to one embodiment, an apparatus for applying a wave-like vacuum to the skin S is shown generally as arrangement 40. Arrangement 40 includes a block member 42 constructed from any suitable material. According to one alternative embodiment, the block member 42 may be constructed from a plastic material such as acrylic resin. According to an exemplary embodiment, block 42 is circular. However, many different shapes can be used and are within the scope of the present invention.

  Block 42 includes an inner annular cavity 44. The cavity 44 communicates with the vacuum port 46. A central port 48 is provided that is configured to contact the surface of the skin. A central port 50 can also be provided through the central post 48, which is in fluid communication with the surface of the skin. The vacuum port can be connected to the waved vacuum source in any suitable manner, such as a suitable fluid connection 52.

  In accordance with the present invention, the central post member 48 is modified, for example, with a concave or convex surface or other advantageously shaped bottom so that the aforementioned beneficial benefits can be more easily achieved when in contact with the skin surface. can do. The central port 50 can be used to collect body fluid and transport it to a remote location. Further, the center post 48 can be configured to have a length different from that of the exemplary embodiment to provide a similar effect as described above.

  However, it should be noted that the use of a vacuum can optionally be prepared to assist in the collection and transport of bodily fluids from the wound site to a remote location. However, the use of this vacuum is not necessary. In this regard, individual hollow capillaries or other similarly configured members can be inserted through the central port 50 to transport bodily fluid samples by capillary action. According to another alternative, a skin penetrating member in the form of a hollow needle can be inserted through the central port 50. The central port is then used to penetrate the skin S to create a wound, and then with or without vacuum and / or capillary action assistance from the wound site to a remote location, It can be used to collect and transport bodily fluid samples.

  Many factors can and are expected to affect the size of the undulating vacuum that can be applied to the wound site. One suitable but non-limiting example of a possible vacuum level is approximately 3.5 psi. One of ordinary skill in the art can determine that other optimal vacuum conditions exist under a particular set of environments in which bodily fluid samples are collected.

  Any suitable means for providing the desired undulating vacuum pressure can be utilized. Illustrative and non-limiting examples are shown in FIGS. 4C and 4D. In the embodiment included in FIG. 4C, the supply connection 52 communicates with the negative pressure source via a three-way fluid valve. The fluid valve 58 is actuated via a solenoid 60 that is connected to a suitable power source 62 by a switch 64. The switch 64 can be manually operated or automated.

An alternative structure that provides a suitable source of undulating vacuum pressure is illustrated by arrangement 66 included in FIG. 4D. In this alternative structure, connection 52 is in fluid communication with a suitable negative pressure source via a two-way fluid valve 70. The valve 70 is actuated by a solenoid 72, which is connected to a power source 74 via a switch 76. The switch 76 can be manually operated or automated.
Additional aspects of the invention include structures and techniques associated with skin penetrating members.

As noted above, a skin penetrating member formed in accordance with the principles of the present invention can have any suitable shape, such as a hollow needle or solid lancet.
According to one embodiment of a skin penetrating member, a skin penetrating member can be formed that includes one or more features shown in FIGS. 5A and 5B. 5A and 5B show a skin penetrating member 500 of the general type of hollow needle. The skin penetrating member 500 includes a tip that includes a beveled or angled surface 502. The surface 502 is oriented in the direction forming an angle β as shown in FIG. 5B. β can include any suitable angle. For example, the angle can be 9 to 19 °.

As described above, the skin penetrating member 500 is in the form of a hollow needle, and therefore the skin penetrating member 500 has both an outer diameter OD that defines the inner bore and an inner diameter ID (see, eg, FIG. 5B).
According to one embodiment, the skin penetrating member 500 is in the form of a so-called “microneedle”. As the name implies, microneedles are characterized by their relatively small diameter. For example, a microneedle can include a skin penetrating member having an outer diameter on the order of 40 to 200 μm, as the term is used herein. The inner diameter can vary, for example, having an inner diameter of about 25 to 160 μm. This needle is also characterized by a gauge display in the art. In the illustrated structure described above, microneedles with gauges ranging from 26 to 36 are clearly included in the present invention. Certain benefits can be collected from the use of such microneedles. In particular, due to their small dimensions, the size of the wound left when entering the skin is relatively small, thereby minimizing the pain associated with such needle insertion and a faster healing process Is possible.

  The skin penetrating member of the present invention can be formed of any appropriate substance. Such materials include polymers, metals, ceramics, glass, silicon and the like. According to one embodiment, the skin penetrating member formed in accordance with the principles of the present invention is comprised of a drawn metal tubing.

  According to another aspect, a skin penetrating member formed according to the principles of the present invention can be provided with a suitable coating on its outer diameter and / or inner diameter. A number of different coatings are possible. For example, the skin penetrating member can be provided with an anti-friction coating that facilitates entry into the skin upon insertion. By reducing friction with the skin, the benefits of pain reduction can be obtained. Any number of suitable antifriction coatings are anticipated. For example, the anti-friction coating can include a polymer-based coating material. One such material is in the form of a hydrophilic / hydrophobic polymer matrix. One example of such a coating material is commercially available under the trade name “SLIP-COAT®”, which is commercially available from STS Biopolymers, Inc. Further, the coating can include silicon. This coating contains a capillary action enhancer or anticoagulant.

  Another exemplary coating material includes a drug or therapeutic agent. For example, one suitable coating material includes an anticoagulant, which acts to prevent clotting of blood that accumulates in the wound, thereby preventing it from newly created wounds caused by insertion of the skin penetrating member. Easy extraction of body fluid samples. As an example, one such suitable coating is generally in the form of a hydrogel, and this layer includes a therapeutic agent therein. One such coating is commercially available under the trade name “MEDI-COAT®”, which is commercially available from STS Biopolymers, Inc.

  A skin penetrating member constructed and utilized in accordance with the present invention can be formed as shown in FIGS. 6A and 6B. As shown therein, the skin penetrating member 600 is generally provided in the form of a hollow needle having an outer diameter OD and an inner bore defining an inner diameter ID. The tip of skin penetrating member 600 includes a plurality of surfaces or beveled surfaces 602, 604. This multi-faceted skin penetrating member 600 can provide certain benefits due to its ease of insertion into the coating, thereby minimizing the associated pain and of the cutting action or wound formation that occurs upon insertion. Make improvements. The skin penetrating member 600 can be formed from any of the aforementioned materials and / or dimensioned according to the above description. That is, the skin penetrating member 600 can also take the form of a “microneedle”.

In accordance with the present invention, numerous other features and modifications can be provided to the skin penetrating member. Various modifications made to the tip of the skin penetrating member are shown in FIGS. 7A-7C.
As shown in FIG. 7A, a skin penetrating member 700 that is generally in the shape of a hollow needle is provided, which has a serrated or corrugated beveled cutting surface 702. This serrated or corrugated cutting surface 702 can provide certain benefits such as improved cutting action or improved wound formation upon insertion of the skin penetrating member 700 into the skin, thereby ensuring proper body fluid flow. Improve sample acquisition.

  Another variation of the skin penetrating member 700 is shown in FIG. 7B and includes a cut-out cutting surface 702 'that is limited to the tip thereof. The benefits provided by this notched surface 702 'are similar to those associated with the skin penetrating member 700 shown in FIG. 7A.

  According to another possible embodiment, the skin penetrating member 700 "can be provided in the form of a generally cylindrical member having a serrated or corrugated generally cylindrical end 702", the cylindrical end being the skin. When inserted into the device, it functions as a rotary cutting device, thereby creating a wound for the collection of appropriate body fluid samples. Thus, according to this particular embodiment, the skin penetrating member 700 "can be rotated when inserted into the skin. The tip or serrated cutting end 702" rotates, thereby allowing collection of a body fluid sample. This produces a cutting action that forms a wound.

As mentioned above, the skin penetrating members 700, 700 'and 700 "can be formed from any suitable material and can be provided with a suitable coating on the inner and / or outer surfaces thereof and / or they are described above. As such, it can be dimensioned to form a microneedle.
Additional features associated with skin penetrating members formed in accordance with the principles of the present invention are illustrated in FIGS. 8A and 8B. The skin penetrating member 800 shown in FIGS. 8A and 8B includes two different components. The first component consists of a substantially hollow needle-like member 802 having an outer diameter OD and an inner bore that limits the inner diameter ID. Needle member 802 includes a beveled leading edge 804. The leading edge 804 can have one or more weakened areas or cuts therein, as shown at 806, 808 in FIG. 8A.

  The second component 810 is an actuator of any suitable structure. As an example, the actuator 810 can take the form of a solid rod-like member that is dimensioned so that it can move freely within the inner diameter of the member 802. The first needle-like member 802 preferably comprises an inner diameter ID that includes a narrower or neck-like reduced portion 812 near its tip. The necked reduced portion 812 acts as an inclined surface in cooperation with the second component 810 as it slides toward the tip of the skin penetrating member 800. As the actuating member 810 contacts the narrowed or necked reduced portion 812, a radially outward force is generated at the tip of the first component 802, causing a splitting mode effect to occur in the weakened area or possibly incision 806, 808. And thereby widen the tip of the first component 802, as shown in FIG. 8B. Such a structure advantageously provides a mechanism that allows the skin penetrating member to be actuated after insertion into the skin in a manner that creates more space in the wound, which then pools blood or bodily fluid within the wound. Providing greater opportunity to do so, and also acts to break any seals that may have been created between the skin penetrating member 800 and the wound tissue.

The skin penetrating member 800 can be formed from any suitable material, can include any suitable coating material, and can be appropriately sized as described above.
An alternative skin penetrating member structure is shown in FIGS. 9A and 9B. Skin penetrating member 900, like skin penetrating member 800 described above, provides a splitting or spreading effect at its tip, which advantageously creates a greater opportunity for pooling blood or bodily fluid within the wound, It acts to break any seal created between the skin penetrating member and the wound tissue. According to the illustrated embodiment, the skin penetrating member 900 includes a first hollow needle-like component 902 and a second component 906. The first component 902 is generally in the form of a hollow needle having a beveled tip 904, a generally cylindrical outer diameter OD, and an inner bore defining an inner diameter ID. Also, the second component 906 is generally in the form of a hollow member, but is dimensioned so that it can move freely within the inner bore of the first component 902. The second component 906 comprises a tip that includes one or more weakened areas, such as 908 and 910, separations or incisions. The second component 906 is formed such that the tip is limited by one or more fingers or spreading members 912, 914, which, under normal circumstances, produce a splash-type force. This force causes the member to naturally diverge radially outward from the longitudinal axis of the second component 906. As shown in FIG. 9A, when the second component 906 is arranged within the inner bore of the first component 902, the radially extending fingers 912, 914 are joined together by the inner diameter ID of the inner bore of the first component 902. To be kept. However, when there is an inner bore at the opposite end or tip of the first component 902, these fingers spread to their natural open position, as shown in FIG. 9B, thereby causing tissue and tissue within the wound site covering. , The aforementioned separation between the ends of the skin penetrating member 900 occurs.

The skin penetrating member 900 can be formed from any suitable material with any suitable coating, and the skin penetrating member 900 can be dimensioned to form a “microneedle”.
A skin penetrating member constructed in accordance with the principles of the present invention may also include various axial features. An example of such a feature configuration is shown in FIGS. 10A-13B. Generally speaking, by providing such an axial feature, the skin penetrating member can be more effective in collecting and transporting an appropriate sample of bodily fluid from the wound site. As described above, the tissue at the wound site can act to seal the end of the skin penetrating member. A complete or partial seal at the end of the hollow needle-like skin penetrating member can clearly have a negative impact on its ability to obtain a fluid sample from the wound site. By providing an axial feature on the skin penetrating member, the sealing effects described above can be avoided and body fluid samples can be more easily collected and transported from the wound site.

  One embodiment of a skin penetrating member formed in accordance with the principles of the present invention is shown in FIGS. 10A and 10B. Skin penetrating member 1000 is generally in the form of a hollow needle having an inner bore 1002 and a generally cylindrical outer surface 1004. One or more spirals or grooves 1006 are formed in the cylindrical outer surface 1004 by any suitable technique. The spiral 1006 can be any suitable shape, such as a plurality of individual bands extending around the entire circumference of the cylindrical surface 1004, or a spiral groove extending axially along the cylindrical outer surface 1004. Can be shaped and shaped. The number and / or size of these spirals 1006 can be varied within the scope of the present invention. Preferably, one or more passages 1008 are provided that extend from the bottom of the one or more spirals 1006 and communicate with the inner bore 1002. Thus, the passage 1008 comprises means for conveying bodily fluids that can be collected in the inner bore 1002 of the skin penetrating member 1000 at the spiral 1006.

  According to an alternative embodiment, skin penetrating member 1100 is shown in FIGS. 11A and 11B. The skin penetrating member 1100 is also generally in the form of a hollow needle with a hollow needle inner bore 1102 and a cylindrical outer surface 1104. At least one axially elongated groove 1106 is cut into the cylindrical outer surface 1104. The axially elongated groove 1106 is cut to a depth such that fluid communication is provided between the cylindrical outer surface 1104 and the inner bore 1102. Thus, bodily fluids can be collected and transported through the axially elongated groove 1106.

  In addition, another alternative skin penetration member structure is shown in FIGS. 12A and 12B. The skin penetrating member 1200 is also generally in the form of a hollow needle having an inner bore 1202 and a cylindrical outer surface 1204. One or more notches 1206 are provided in the cylindrical outer surface 1204. The notch 1206 can be formed by any appropriate technique such as mechanical processing, chemical etching, or the like. Additionally, one or more passageways 1208 are provided that communicate with the bottom of the at least one notch 1206 and the inner bore 1202. Thus, bodily fluids can be collected in one or more notches 1206, which in turn communicate with the inner bore 1202 of the skin penetrating member 1200.

  Another alternative structure for a skin penetrating member constructed in accordance with the principles of the present invention is shown in FIGS. 13A and 13B. Skin penetrating member 1300 is generally configured as a hollow needle having an inner bore 1302 and a cylindrical outer surface 1304. At least one axially extending notch is provided in the cylindrical outer surface 1304. Additionally, at least one passage is provided in communication with the bottom of the notch 1306 and the inner bore 1302. The notch can then communicate with the inner bore 1302 via at least one passage 1308.

Similar to the previous embodiments, the skin penetrating members shown in FIGS. 10A-13B can be formed from any suitable material, and can include one or more suitable coatings, for example, It can be appropriately sized to form a “microneedle”.
Another aspect of the present invention can be generally described as an arrangement and technique that provides a fluid path for transporting a bodily fluid sample that is separate from the device that creates the wound itself. Three examples are shown in FIGS. Although all examples include concentric members, it will be appreciated that the invention need not be so limited. For example, the skin penetrating member and the separate bodily fluid collection device can be arranged side-by-side or entirely independently of each other and still appear to be within the scope of this aspect of the invention.

  Apparatus, arrangements and techniques constructed or implemented in accordance with this aspect of the invention can provide certain benefits. First, as described above, when a skin penetrating member is inserted into the skin, the body often tries to form a seal around the penetrating member to prevent loss of blood from the body. react. This sealing effect can suppress the ability of the device to collect and transport body fluid samples from the wound site. Therefore, this aspect of the present invention provides a solution to this problem because at least one concentric member can be handled in a manner that the sealing effect described above does not adversely affect the ability of the device to collect and transport bodily fluid samples. I will provide a. In addition, the use of separate members for flaw generation and sample transport also provides an opportunity to maximize the properties of the member material according to their desired function. For example, the bodily fluid transport member can be composed of a material such as reinforced plastic that promotes capillary action, thereby making it more effective in transporting bodily fluid samples than a member that creates wounds. The material utilized for the flaw-generating member can be optimized with respect to the properties important for performing this function, i.e. structural integrity, coefficient of friction, etc. In addition, multiple fluid passages can be provided in accordance with this aspect of the invention. Thus, for example, gas can be introduced into the wound site with positive pressure through one of the fluid passages, thereby expanding the wound site and helping to pool body fluid samples for collection and delivery. At the same time or thereafter, a vacuum can be applied to another separate fluid path, thereby facilitating collection and transport of bodily fluid samples from the wound site.

Specific examples are described below.
One such multi-component skin penetrating member 1400 is shown in FIG. According to the illustrated example, an outer member 1402 is generally provided in the form of a hollow needle having a cylindrical outer surface 1404, an inner bore 1406, and a beveled leading edge 1408. The second component 1410 is generally in the form of a hollow tube having an inner bore 1412 and a cylindrical outer surface 1414. Tubular member 1410 is axially translatable within inner bore 1406 of needle member 1402. In accordance with the present invention, the second generally tubular member 1410 can include an axial feature such as that described above. Illustratively, one or more passages 1416 are formed in the cylindrical outer surface 1414 that communicate with the inner bore 1412 of the hollow tubular member 1410. These passages increase the ability of the tubular member 1410 to collect and transport body fluid from the wound site.

  As noted above, components 1402 and 1410 can be composed of any suitable material. By way of example only, the first member 1402 is in the form of a needle having a dimension on the order of 26 gauge and may be formed from a drawn metal tubing material. The second component 1410 can be formed from a suitable polymer material, such as a polyetherimide (PEI) material in the form of a tube with dimensions that are free to move within the inner bore of the first component 1402. . For example, the tubular component 1410 can have an outer diameter on the order of 0.008 inches.

  The skin penetrating member 1400 can provide certain benefits. For example, the outer needle member 1402 can be used to create a wound on the skin. After insertion into the skin, the inner tubular member 1410 translates within the axial bore 1406 and can extend beyond the end of the acicular member 1402 so that the end of the acicular member 1410 and the body tissue at the wound site Any seal formed between the two can be broken. Also, the extension of the tubular member 1410 creates a larger space at the end of the needle member 1402, thereby creating a greater opportunity to pool blood or bodily fluid at the wound site. A body fluid sample can be collected by the tubular member 1410 through the inner bore 1412. An axial feature, such as passageway 1416, facilitates the collection of bodily fluid from the wound site when present. As described above, the tubular member 1410 can be composed of a material that provides advantageous properties to perform its function. For example, the tubular member 1410 can be made of or coated with a material that enhances the capillary action of fluid flowing through the inner bore 1312. Vacuum pressure can also be applied to the inner bores 1406 and / or 1412 to enhance the ability of the device to collect and transport bodily fluid samples. In addition, gas under positive pressure can be introduced into the wound site via the inner bores 1406 and / or 1412 and passages 1416, if any, thereby expanding the wound site and pooling blood or body fluids. Provide greater opportunities. Samples can be collected only by capillary action or assisted by vacuum pressure.

  According to another example, a skin penetrating member 1500 is shown in FIG. Arrangement 1500 carries something similar to arrangement 1400 described above. Arrangement 1500 includes an outer needle 1502 having a cylindrical outer surface 1504, an inner bore 1506, and a beveled tip surface 1580. The second component 1510 of the arrangement 1500 can be provided in the form of a concentric hollow needle-like member having a cylindrical outer surface 1514, an inner bore 1512 and a beveled or angled front surface 1516. Inner needle member 1510 translates axially within inner bore 1506 of outer needle member 1502.

  The arrangement 1500 can be utilized in a manner similar to that described above with respect to the arrangement 1400 of FIG. In this regard, although not shown, it is within the scope of the present invention to provide an inner needle 1510 having an “axial feature” such as that described above with respect to other embodiments of the present invention.

  Further, because the inner member 1510 is in the form of a hollow needle, preferably after the inner needle member 1510 is retracted, the inner needle member 1510 can respond to wound site generation and the outer needle member 1502. It is possible to utilize the arrangement 1500 in a manner that makes it responsive to collecting and transporting bodily fluid samples from the wound site. Of course, to create the wound site, the outer needle 1502 is inserted and then the end of the outer needle 1502 is added to increase the wound area, thereby facilitating a pool of blood or bodily fluid samples. It is possible to extend the inner needle member 1510 from its end to break any seal formed in the. Further, as described above, the inner needle member 1510 can extend from the end of the outer needle member 1502 and then collect a body fluid sample from the wound site by capillary action or a combination of both, assisted by vacuum. Can be used for. It is also possible to further manipulate the inner and / or outer members 1502, 1510. For example, the inner member 1510 can be rotated to increase the cutting action during wound creation and manipulation.

  Yet another example is shown as arrangement 1600 in FIG. This arrangement provides an outer member 1602 in the form of a generally hollow needle-like member having a cylindrical outer surface 1604, an inner bore 1606 and an angled tip surface 1608. A second component of this arrangement 1610 in the form of a substantially solid lancet is provided, which includes a beveled or angled solid front surface 1612 and a cylindrical outer surface 1614. With this arrangement, the lancet-shaped inner member 1610 can be utilized to extend from the inner bore 1606 of the outer needle-like member 1602 to initially create a wound in the skin, and then the outer hollow needle-like member. 1602 can function to collect and transport a bodily fluid sample from a wound site. Alternatively, the outer hollow needle member 1602 can be used for initial wound creation, and the inner lancet type member 1610 can be used to break any seal formed at the end of the needle member 1602 and blood Or it can extend from the end of member 1602 to increase the wound site area at the end of member 1602 to facilitate pooling of bodily fluid samples.

Another aspect of the present invention is to provide a skin penetrating member with a cross-section that can provide certain benefits, such as an increased probability of producing a body fluid sample that can be collected upon insertion into the skin. Including. One embodiment of this aspect of the invention is shown in FIGS. 17A-17C.
This illustration is in the form of a needle 1700 that includes a cylindrical outer surface 1702, an inner bore 1704, and a beveled or angled front surface 1706. Skin penetrating member 1700 can be generally described as a “flat” needle. As shown in FIG. 17C, this “flat” needle structure is characterized by a width dimension W that is significantly greater than its thickness dimension T. Illustratively, the width can be two to three times greater than the thickness T.

The cross-section of the needle increases the probability of cutting through a body fluid producing element contained under the surface of the skin, such as a capillary, when such a flat needle is inserted into the skin.
As described above in connection with previous embodiments, skin penetrating member 1700 can be formed from any suitable material, can include one or more suitable coatings, and is appropriately sized. be able to. According to one non-limiting example, skin penetrating member 1700 can initially be provided in the form of a 34 gauge (or 36 gauge) hypodermic needle, which is then It is flattened by a suitable process such as rolling so that its width dimension W is 2 or 3 times greater than its thickness dimension T.

  Additional aspects of the present invention include techniques for manipulating the skin penetrating member for wound creation and wound manipulation. Techniques implemented in accordance with the principles of the present invention are believed to be advantageous at least in the area of reliable and effective acquisition of bodily fluids, minimization of invasiveness, and / or pain reduction.

One embodiment of a technique implemented to conform to the principles of the present invention is shown in FIGS. 18A and 18B.
According to this embodiment, skin penetrating member 1800 is inserted into the surface of skin 1802 thereby forming a wound W. There are various skin penetrating member parameters that can be adjusted according to the present invention. For example, arrangements such as those previously described herein can be utilized to control the speed, depth and timing of one or more insertions of the skin penetrating member.

  With respect to speed, a normal skin penetrating member, such as a lancet, is typically pushed into the surface of the skin at a very high speed. While such speeds are possible, a skin penetrating member, such as a hollow needle, can be inserted into the surface of skin 1802 at a much lower rate than is typically utilized when pushing a lancet into the surface of the skin. Can do. Illustratively, as mentioned above, a skin penetrating member in the form of a hollow needle can be pushed into the skin at a rate of progression of approximately 1 to 4 meters / second. The timing can be controlled, possibly in an automatic manner, when one or more skin penetrating members are inserted into the surface of the skin. The skin penetrating member can be automatically inserted into the surface of the skin at scheduled intervals when utilized in the context of obtaining a body fluid sample for analysis to determine the concentration level of glucose. These intervals can be equal or standard, such as every 2 to 3 hours. Alternatively, needle insertion timing can be calculated based on previous test results so that more frequent sampling is performed when the glucose level in the body falls outside an acceptable range.

  The depth to which the skin penetrating member is pushed into the surface of the skin 1802 can also be controlled. For example, when trying to obtain a blood sample, a penetration depth that is too shallow often results in the capillaries that provide an abundant blood source not being cut, thereby losing the proper blood sample. If the penetration depth is too deep, problems that have been experienced include the body's natural tendency to form a seal around objects that penetrate the skin. Thus, this self-sealing problem is often encountered at larger penetration depths.

  Thus, according to the principles of the present invention, skin penetrating member 1800 is inserted into the surface of skin 1802 to such a depth that it penetrates capillary bed 1804. By penetrating capillary bed 1804, an appropriate number of capillaries are cut or broken to create an appropriate triple of body fluid such as blood. This step is specified in FIG. 18A.

  Further, to avoid the self-sealing problem described above, the skin penetrating member 1800 can be at least partially extracted from its initial penetration depth, as shown in FIG. 18B. This withdrawal of the skin penetrating member 1800 avoids the self-sealing problem described above because it creates a space between the end of the skin penetrating member and the bottom of the wound W, as shown in FIG. 18B. Body fluid BF is then allowed to pool in the space created at the bottom of the wound.

  This pooled bodily fluid BF can then be collected by any suitable member or technique. When the skin penetrating member 1800 is in the form of a hollow needle, the body fluid BF can be drawn through its inner bore. Body fluid can be collected by capillary. It can be pulled through the inner bore either by section, vacuum or a combination thereof.

  Alternatively, a separate member, such as a concentric tubular member (see, eg, FIG. 14), can be utilized to draw a sample of bodily fluid BF from within the wound W. Alternatively, although not shown in FIG. 18B, the body fluid BF is allowed to pool to the extent that it completely fills the wound and then forms drops on the outer surface of the skin 1802. Body fluid BF can then be drawn from the top surface of skin 1802 by any suitable technique, such as those described above.

In accordance with the present invention, the skin penetrating member 1800 can be manipulated in a number of different ways to provide the desired result. The skin penetrating member can be manipulated either during insertion or after initial wound formation.
As shown in FIG. 18A, the skin penetrating member 1800 may be rotated by R, reciprocated, and / or articulated by any number of different angles AR. Manipulation of these skin penetrating members manipulates the wound to cut or break more capillaries, thereby maximizing the volume and probability of body fluid or blood acquisition, for example, expanding the wound and thereby abundance. And / or to increase the chances of pooling of body fluids and / or break any seals that may occur between the skin penetrating member 1800 and various components of the skin, such as 1802, 1804.

  Additional embodiments of techniques implemented in accordance with the principles of the present invention are shown in FIGS. 19A-19D. According to the illustrated embodiment, skin penetrating member 1900 is inserted into the surface of skin 1902. Various needle insertion parameters such as speed, depth, and timing can be controlled as described above. Furthermore, the skin penetrating member 1900 can be manipulated as described above, for example, by rotation, forward movement, and / or articulation of several different angles AR.

Preferably, skin penetrating member 1900 is inserted deep enough to penetrate into capillary bed 1904 contained below the surface of skin 1902.
Thereafter, the skin penetrating member 1900 is completely pulled out from the wound W as shown in FIG. 19B. Thus, the self-sealing effect around the skin penetrating member 1900 described above is thereby avoided.

  Thereafter, the body fluid BF allowed to pool in the wound W is collected. Several different possibilities are possible for the technical stage. According to the first option, as shown in FIG. 19C, when the skin penetrating member 1900 is in the form of a hollow needle, the skin penetrating member is re-introduced into the wound to an extent sufficient to receive a pool of BF. It is only inserted.

  Alternatively, as shown in FIG. D, when the skin penetrating member 1900 is in the form of a hollow needle, the skin penetrating member 1900 can reapply to the wound W, but drops a drop on the top of the skin 1902 surface. In order to access a sample of bodily fluid BF that is allowed to pool and form, it is stopped nearby. As mentioned above, additional techniques for manipulating wounds such as, for example, mechanical, thermal, or other methods can be utilized with the above-described embodiments to promote the pooling effect of body fluid BF. This is true for all of the aforementioned techniques.

In addition, once pooling is allowed to occur, several different possibilities exist for collecting a sample of body fluid BF.
For example, an arrangement such as that shown in FIG. 14 that includes a hollow needle member that is axially translatable can be utilized to collect a body fluid BF sample. Therefore, according to this aspect of the present invention, once skin penetrating member 1900 is inserted into the surface of skin 1902 forming wound W, skin penetrating member 1900 is pulled out. Subsequently, the inner tubular member, or other device, is approached to the pooled sample of bodily fluid BF, as shown in FIGS. 19C and 19D, either within the wound itself W or on the surface of the skin 1920. Made either way.

  As mentioned above, one aspect of the present invention is the ability to control or automate some, if not all, parameters of insertion and operation of the skin penetrating member. In this regard, according to another aspect of the present invention, skin sensor placement can be utilized to simplify the aforementioned control, operation and / or automation of placement and techniques for bodily fluid sampling.

  One possible skin penetrating member 2000 formed in accordance with the principles of the present invention is shown in FIG. Arrangement 2000 is configured in a manner that provides the ability to detect contact between skin penetrating member 2002 and the surface of skin 2004. It is also expected that the arrangement 2000 can be configured such that it can detect depth or distance from the surface of the skin 2004. According to the illustrated embodiment, the skin penetrating member 2002 is in electrical communication with the remaining elements of the circuit or arrangement 2000. According to a preferred embodiment, the skin penetrating member 2002 is electrically conductive. In this regard, the skin penetrating member 2002 can be comprised of a hollow needle or a solid lance type member.

A high gain or transimpedance amplifier 2006 is provided, which is electrically connected to the skin penetrating member 2002, grounded at the 2008 point, and can also be connected to any resistance device 2010. According to one embodiment, amplifier 2006 is powered by a power source to facilitate output amplification. By way of example only, amplifier 2006 may be operated with a 5 volt power source. The amplifier 2006 can detect very small changes in current that communicates with the amplifier through the conductive skin penetrating member 2002. According to the present invention, a current of about 10 ⁻¹⁰ amperes or a current change is appropriate.

  These currents flowing through the skin penetrating member 2002 are picked up by the amplifier 2006 and then output to the remaining circuits. Several alternative structures for the rest of the circuit are envisioned. For example, the signal output by amplifier 2006 can be sent to signal conditioning software and circuitry (not shown) for further processing. Similarly, the signal output by amplifier 2006 also translates the data independently or continuously to a microprocessor (not shown) that can translate the data, generate information, and produce the desired output. Can send.

Thus, as will be apparent from the foregoing, slight changes in the current generated in the skin penetrating member 2002 can be detected, amplified, and output to produce a signal 2012 indicating that.
When skin penetrating member 2002 contacts the surface of skin 2004, a detectable change in current level occurs and is sent to amplifier 2006. The amplifier then produces an output in response, which, after any additional processing, produces a signal 2012 that can be interrupted when indicating contact of the skin penetrating member 2002 with the surface of the skin 2004. it can.

Numerous uses and applications of the arrangement 2000 and the resulting output signal 2012 are envisioned.
One such technique that utilizes the above-described concept is described below. A device or arrangement is provided that can insert the skin penetrating member into the skin surface. The device is programmed so that once the skin surface is sensed, the device causes the skin penetrating member to be inserted into the skin for a predetermined desired distance. After its insertion, the device can be programmed to partially or fully withdraw the skin penetrating member to some location outside the skin. Furthermore, the device and / or arrangement can also be programmed to re-access the skin and sense the skin surface again. Once the skin surface is sensed, the program can either stop the advancement of the skin penetrating member or reinsert the skin penetrating member into the skin. Devices or arrangements that sense the presence of blood can also be incorporated. Thus, when the skin penetrating member reappears and senses the skin surface, the blood sensing device is used to sense the presence of bodily fluid and then perform a bodily fluid collection routine that depends on the results of this investigation. Can do. Thus, if blood is sensed on the skin surface, the skin penetrating member will not advance any further and a body fluid sample may be collected from the skin surface. If blood is not sensed on the skin surface, a skin penetrating member or a separate body fluid collection member can be reinserted into the skin to reincision the wound to improve the pooling action of body fluid and / or from within the wound Improve collection of body fluid samples.

  As a possible modification, an arrangement such as that shown in FIG. 20 may not only detect the surface of the skin, but also detect the presence of blood based on a small current difference that occurs when contacting the skin penetrating member. Therefore, it is obvious that it can be used. Another possible modification of the above concept is the initial extension of the skin penetrating member towards the skin surface, sensing contact between the skin surface and the skin penetrating member, extending the planned distance of the skin penetrating member below the skin surface Retraction of the skin penetrating member to its starting or home position, re-extension of the skin penetrating member towards the skin surface where the skin surface is detected via the skin penetrating member, and then the body fluid sample is pooled to the skin surface Or detecting whether it continues to return to the skin surface automatically for a predetermined distance less than or equal to the initial depth of penetration.

The arrangements and techniques described above are clearly exemplary, and it will be apparent to those skilled in the art that many changes can be made using the basic concepts of the invention.
The above embodiments of the present invention are illustrative and do not represent every possible embodiment of the present invention. It goes without saying that various changes may be made to the disclosed embodiments without departing from the spirit and scope of the present invention.

1 is a perspective view of one embodiment of a bodily fluid sampling device constructed in accordance with the principles of the present invention. 1 is a cross-sectional view of a bodily fluid sampling device constructed according to the principles of the present invention. 1 is a perspective view of a mechanical stimulator constructed in accordance with the principles of the present invention. It is sectional drawing taken along line 3B-3B of FIG. 3A. 1 is a bottom view of one embodiment of a vacuum assisted operating device constructed in accordance with the principles of the present invention. FIG. It is sectional drawing taken along line 4B-4B of FIG. 4A. 1 is one embodiment of an arrangement for providing vacuum pressure to a vacuum assisted operating device. FIG. 6 shows an alternative structure for providing vacuum pressure to a vacuum assisted operating device. It is a top view of one Example of the skin penetration member according to this invention. It is a side view of the skin penetration member of FIG. 5A. FIG. 6 is a top view of an alternative embodiment of a skin penetrating member. FIG. 6B is a side view of the skin penetrating member of FIG. 6A. FIG. 6 is a side view of another alternative embodiment of a skin penetrating member constructed in accordance with the principles of the present invention. It is a side view of another Example of a skin penetration member. It is a side view of another Example of a skin penetration member. 1 is a top view of one embodiment of a skin penetrating member constructed in accordance with the principles of the present invention. FIG. It is a top view of the skin penetration member of FIG. 8A after expansion. 1 is a top view of one embodiment of a skin penetrating member configured to conform to the principles of the present invention. FIG. FIG. 9B is a top view of the skin penetrating member of FIG. 9A after expansion. It is a top view of the structure of the skin penetration member as an alternative. FIG. 10B is a side view of the skin penetrating member of FIG. 10A. FIG. 6 is a top view of another alternative structure for a skin penetrating member constructed in accordance with the principles of the present invention. FIG. 11B is a side view of the skin penetrating member shown in FIG. 11A. It is a top view of the structure as another alternative of a skin penetration member. FIG. 12B is a side view of the skin penetrating member shown in FIG. 12A. It is a top view of the structure as another alternative of a skin penetration member. It is a side view of the skin penetration member of FIG. 13A. It is a perspective view of one Example of the skin penetration member comprised according to the principle of this invention. FIG. 6 is a perspective view of an alternative structure for a skin penetrating member constructed in accordance with the principles of the present invention. FIG. 6 is a perspective view of yet another alternative structure for a skin penetrating member configured to conform to the principles of the present invention. FIG. 6 is a top view of an alternative structure that can be provided to a skin penetrating member consistent with the principles of the present invention. FIG. 17B is a side view of the skin penetrating member of FIG. 17A. FIG. 17B is a cross-sectional view taken along line 17-17 of FIG. 17B. FIG. 3 shows one step of a bodily fluid sampling technique implemented to be consistent with the principles of the present invention. FIG. 5 is a diagram illustrating other steps performed in accordance with the technique of one embodiment of the present invention. FIG. 3 is a diagram illustrating one step taken in the execution of a technique for obtaining a bodily fluid sample performed in accordance with the principles of the present invention. FIG. 5 illustrates another step of the technique performed in accordance with the principles of the present invention. FIG. 5 illustrates yet another step taken in accordance with a technique implemented to be consistent with the principles of the invention. FIG. 5 shows yet another step performed in accordance with a technique for obtaining a body fluid sample consistent with the principles of the present invention. 1 is a schematic diagram of a skin-sensor arrangement configured in accordance with one embodiment of the present invention. FIG.

Claims (77)

At least one skin penetrating member;
An actuator for extending and / or retracting at least one skin penetrating member;
A controller for controlling the actuator;
At least a skin penetrating member and a housing for mounting the actuator;
A device operable to extract a bodily fluid sampling characterized by comprising: The apparatus of claim 1, further comprising an attachment mechanism for attaching the apparatus to a wearer. The apparatus of claim 2, wherein the attachment mechanism includes a strap. The apparatus of claim 2, wherein the attachment mechanism includes an adhesive. 2. A device according to claim 1, wherein the body fluid consists entirely of blood. The apparatus of claim 1, wherein the skin penetrating member includes a lancet. The apparatus of claim 1, wherein the at least one skin penetrating member includes at least one microneedle having a diameter of approximately 40 to 200 micrometers. The apparatus of claim 1, wherein the at least one skin penetrating member includes one microneedle having an inner diameter of approximately 25 to 160 micrometers. The apparatus of claim 1, wherein the apparatus is operable to extend at least one microneedle to a maximum penetration depth of approximately 2.5 mm. The device of claim 1, wherein the device is operable to extend at least one skin penetrating member to a maximum length of approximately 8.0 mm. The apparatus of claim 1, wherein the at least one skin penetrating member has a tip sharpened to an angle of approximately 9 to 19 degrees. The apparatus of claim 1, wherein the at least one skin penetrating member has a corrugated tip. The apparatus of claim 1, wherein the at least one skin penetrating member has a sharpened tip including a plurality of facets. The at least one skin penetrating member has a hollow cylindrical body that includes a cylindrical outer surface and an inner bore, and the at least one skin penetrating member further includes at least one in the cylindrical body that defines a passage through the outer surface into the inner bore. The apparatus of claim 1 including one hole. The at least one skin penetrating member has a hollow cylindrical body including a cylindrical outer surface and an inner bore, and the at least one skin penetrating member further includes at least one axial slot or groove formed in the outer surface. The apparatus of claim 1. The device of claim 1, wherein the at least one skin penetrating member has at least one spiral. The at least one skin penetrating member has an inner bore and the apparatus further includes at least one axially movable hollow tubular member concentrically housed within the inner bore of the at least one skin penetrating member. The apparatus according to claim 1. The at least one skin penetrating member has an inner bore, and the apparatus further comprises at least one additional axially movable skin penetrating member arranged in the inner bore. apparatus. The apparatus of claim 1, wherein the at least one skin penetrating member has an inner bore and the apparatus further comprises at least one axially movable lance arranged in the inner bore. The apparatus of claim 1, further comprising at least one axially movable tube arranged about the skin penetrating member. The apparatus of claim 1, wherein the at least one skin penetrating member includes an expanding needle. The device of claim 1, wherein the at least one skin penetrating member includes a flat needle. The device of claim 1, wherein the at least one skin penetrating member includes a coating disposed on an outer surface thereof. 24. The apparatus of claim 23, wherein the coating includes a lubricant. 24. The device of claim 23, wherein the coating comprises a non-reactive hydrophilic / hydrophobic matrix. 25. A device according to claim 24, wherein the coating comprises a pain reducing agent. The device of claim 1, wherein the at least one skin penetrating member includes a coating disposed within the inner bore, the coating including a capillary action enhancer. 28. The device of claim 27, wherein the coating includes an anticoagulant. In the device for body fluid extraction,
At least one skin penetrating member having an inner bore and an outer diameter;
At least one axially movable hollow tubular member disposed within the inner bore;
The apparatus characterized by including. At least one skin penetrating member is cylindrical at the cylindrical outer surface, a first end region having a distal sharpened tip, a second axially opposite end region, and a second end region. The apparatus of claim 1 including a hollow tubular member fitted on the outer surface. The apparatus of claim 1 further comprising a hub member secured to the cylindrical outer surface at the first end region. The apparatus of claim 1, further comprising a syringe body attached to the hub. The hollow tubular member includes a first end region fitted on the cylindrical outer surface of the at least one skin penetrating member and an axially opposite second end, and the device further includes a first end of the tubular member. 33. The device of claim 32, comprising a fluid coupling member attached to the two ends. The device according to claim 1, wherein the controller and / or actuator is operable to rotate at least one skin penetrating member. The controller and / or actuator is operable to be at least partially withdrawn after penetrating at least one skin penetrating member through the wearer's skin while remaining inserted into the wearer's skin. The apparatus according to claim 1. The apparatus of claim 1, wherein the controller and / or actuator is operable to actuate the needle at a rate of approximately 1 to 4 meters / second. The apparatus of claim 1, wherein the controller and / or actuator is operable to repeatedly extend and retract at least one skin penetrating member during a single sampling operation. The apparatus of claim 1, wherein the actuator comprises an electromechanical device. The apparatus of claim 1, wherein the actuator comprises a DC stepper motor. The apparatus of claim 1 including an actuator spring. The apparatus of claim 1, further comprising a heat stimulation member for stimulating the wearer's skin. The apparatus of claim 1, further comprising a mechanical stimulation member for stimulating the wearer's skin. 43. The device of claim 42, wherein the mechanical stimulation member includes a mechanism for pinching the wearer's skin. 44. The apparatus of claim 43, wherein the mechanism for mechanically stimulating the wearer's skin includes means for applying a vacuum to the wearer's skin. The apparatus of claim 1, further comprising puncturing the skin surface and then inserting at least one skin penetrating member into the wearer near the punctured skin surface. The apparatus of claim 1, further comprising a mechanism for applying pressure to the wearer's skin after insertion of the at least one skin penetrating member. The at least one skin penetrating member includes an inner bore, and the device further includes a vacuum device for applying a vacuum to the inner bore while the at least one skin penetrating member is extended into the wearer's skin. The apparatus of claim 1. The vacuum device applies reversible so that a positive pressure is applied to the inner bore while the at least one skin penetrating member is extended into the wearer's skin. Item 48. The apparatus according to Item 47. 48. The apparatus of claim 47, wherein the vacuum apparatus is capable of applying a variable vacuum to create a wave in the vacuum pressure applied to the inner bore. 48. The apparatus of claim 47, wherein the vacuum apparatus is capable of applying a vacuum of approximately 0.18 to 0.25 psi. 48. The apparatus of claim 47, wherein the means for applying a vacuum comprises an electroacoustic device. 57. The apparatus of claim 56, further comprising a mechanism that renders the wearer insensitive before inserting at least one skin penetrating member. The apparatus of claim 1, further comprising a skin sensor. 54. The apparatus of claim 53, wherein the skin sensor measures an electrical parameter of at least one skin penetrating member. 55. The apparatus of claim 54, wherein the skin sensor includes an electrical circuit operable to detect when at least one skin penetrating member contacts the surface of the skin. The device of claim 1, wherein the housing allows the at least one skin penetrating member to extend from the device at a non-orthogonal angle relative to the surface of the skin into which it is inserted. 57. The apparatus of claim 56, wherein the non-orthogonal angle is approximately 10 to 40 degrees. In the body fluid sampling device,
At least one skin penetrating member;
An actuator for extending and / or retracting at least one skin penetrating member;
A controller for controlling the actuator;
At least one skin penetrating member and a housing for mounting the actuator;
A skin sensor for measuring an electrical parameter transmitted through at least one skin penetrating member;
A bodily fluid sampling device comprising: 59. The apparatus of claim 58, further comprising a base and a frame, wherein the actuating means is mounted on the frame, and the frame is pivotally attached to the base. 60. The apparatus of claim 59, wherein the base includes a guide member operable to guide the at least one skin penetrating member when the skin penetrating member is extended through the guide member by the actuating means. 59. The device of claim 58, wherein the housing allows the at least one skin penetrating member to extend from the device at a non-orthogonal angle relative to the skin surface into which it is inserted. 62. The apparatus of claim 61, wherein the non-orthogonal angle is approximately 10 to 40 degrees. (I) inserting at least one skin penetrating member into the skin a predetermined distance at the sampling site;
(Ii) retracting at least one skin penetrating member at least partially from the predetermined distance; and (iii) withdrawing a body fluid sample from the sampling site;
A method for extracting a body fluid sample comprising: 64. The method of claim 63, wherein the sample comprises at least one of blood and interstitial fluid. 64. The method of claim 63, wherein the at least one skin penetrating member comprises a lancet. 64. The method of claim 63, wherein the at least one skin penetrating member comprises a microneedle. 64. The method of claim 63, wherein step (i) includes inserting at least one skin penetrating member at an angle of 10 to 40 degrees relative to the surface of the skin. 64. The method of claim 63, comprising retracting at least one skin penetrating member to the extent that the skin penetrating member is still located below the surface of the skin. 64. The method of claim 63, wherein step (ii) comprises retracting at least one skin penetrating member to an extent that the skin penetrating member is completely withdrawn from the skin. 69. The method of claim 68, wherein step (iii) comprises withdrawing the sample from below the surface of the skin. 70. The method of claim 69, wherein step (iii) comprises withdrawing the sample from below the surface of the skin. 64. The method of claim 63, wherein step (iii) includes withdrawing the sample through the inner bore of the skin penetrating member. 64. The method of claim 63, wherein step (iii) comprises withdrawing the sample at least partially by capillary action. 64. The method of claim 63, wherein step (iii) comprises withdrawing the sample at least partially by vacuum pressure. 64. At least one of steps (i) and (ii) further comprises rotating; reciprocating; and / or angularly articulating at least one skin penetrating member. The method described in 1. The at least one skin penetrating member includes a needle having an inner bore, and step (iii) further comprises extending the hollow tubular member axially from the inner bore of the needle and withdrawing the sample through the hollow tubular member. 64. The method of claim 63, comprising. 64. The method of claim 63, wherein at least one of steps (i) and (ii) comprises sensing a penetration depth and / or a retraction distance of at least one skin penetrating member. .

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